Over-the-Counter Human Drugs; Labeling Requirements

ICR 200203-0910-001

OMB: 0910-0340

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
5942
Migrated
ICR Details
0910-0340 200203-0910-001
Historical Active 199903-0910-005
HHS/FDA
Over-the-Counter Human Drugs; Labeling Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 04/22/2002
Retrieve Notice of Action (NOA) 03/14/2002
  Inventory as of this Action Requested Previously Approved
06/30/2005 06/30/2005 05/31/2002
39,910 0 39,932
120,525 0 120,578
0 0 0

The FDA regulations governing labeling requirements for human OTC drug products provide for a standardized content and format for all products. The outside container or wrapper of the retail package (or the immediate container label if there is no container or wrapper) of all OTC drug products contain uniform headings and subheadings, presented in a standardized order, with standardized order, with standards for type size and other graphic features. The requirements are intended to enable consumers to better read and undersand OTC product labeling and apply this information to the safe and effective use of OTC.....

None
None


No

1
IC Title Form No. Form Name
Over-the-Counter Human Drugs; Labeling Requirements

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 39,910 39,932 0 0 -22 0
Annual Time Burden (Hours) 120,525 120,578 0 0 -53 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
03/14/2002


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